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Notified Body Deficiency Response

Notified body deficiency rounds answered from the manufacturer's own technical file, with each repeated question set beside the answer that missed it and a citation on each value.

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Follow item 2.07 from a gap to a signed round ↓
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The problem

A question asked twice means the last answer missed what was asked

The letter arrives as a portal download. Someone pastes each numbered item into a tracker, emails it to an owner, and the owners search the technical file, risk records and lifecycle system by hand. Answers get assembled with tracked changes and argued over in meetings.

Whether a new item repeats an old one is caught only if someone remembers the old answer. So the same table goes back a second time, a test report run on an older firmware slips into the file, and an answer cites a label revision that was superseded last week. Each of those buys another round.

Built forRegulatory affairs leadsRegulatory signatoriesDesign quality engineersClinical evaluators

The Problem Today

Notified bodies ask the same question twice when the first answer missed the point, and each round costs months.

13–18 mo
usual wait for a quality system and product certificate published

Done by hand today

  • Splitting
  • Searching
  • Comparing
  • Retyping
  • Old answer, same missNobody sets the first answer beside the new question
  • Tested build not releasedEvidence from older firmware slips into the file

The Solution

  1. Letter split, item by itemEach question kept word for word, graded and mapped to its file part
  2. Repeats set side by sideFirst question, our old answer and the new wording, and what was missing
  3. Answers cite their pageEach value traced to the protocol, report or risk file page it rests on
  4. Maker, checker, sign-offA second person reads each answer; the signatory opens a sample

Built-in controls

  • Post-market items go to their team unread
  • Gaps get an owner and a date, never words
  • A maker can never check their own answer

What You Get

Regulatory teams send each round on time, with each repeated question answered by what it asked.

24 hrs
saved per response round: 30% of 80 hours our estimate
  • Tested build matchedFirmware and board revisions checked before an answer goes
  • Open reviews on one clockEach open round with its due date and owner
  • A signed pack to uploadEach answer with its evidence list and signatures, ready to upload
Two days before the response is due

A notified body deficiency asked twice: item 2.07 on the morning it closes

Round 2 of a technical documentation assessment for a powered linear cutter. Twenty-two items are final or owned. One repeat is still a gap, and a protocol was linked at 8:12.

demoEverything here is sample data: the cutter, its maker, the staff, the documents and each number.

  1. 0108:40

    23 deficiencies in Round 2, and 22 of them are already final

    Regulatory affairs manager

    The review is drawn as rounds: Round 1 closed on the left, Round 2 in the middle, promised gaps dotted in Round 3. Rows are technical file parts. Eighteen items are answered and checked, three are gaps with owners and one sits with the post-market team. The panel on the right names her next step: re-read 2.07.

  2. 0208:41

    Six of the 23 came back from Round 1, each tied to its first number

    Regulatory affairs manager

    With repeats filtered, the old Round 1 tokens stay lit beside the new ones: 2.03 from 1.04, 2.07 from 1.12, 2.12 from 1.19 and three more. She makes the repeats herself, because a repeat means the wording failed once. The engineer who owns the topic checks them.

  3. 0308:42

    Item 2.07 asks why 30 units, and the first pass found nothing to cite

    Regulatory affairs manager

    The letter wants the sample size of 30 per reload size justified and the statistical method stated. When the letter came in, the agents found no rationale anywhere and marked it a gap. At 8:12 the design quality engineer linked the verification protocol, rev C. Nothing in it has been read yet, and the page says so.

  4. 0408:43

    The re-read opens the protocol and finds the rationale on page 4

    Regulatory affairs manager

    She starts the re-read and watches each step land. The round matcher sets 1.12 against the Round 1 answer. The evidence finder opens all 11 pages and stops at section 5.2: a one-sided lower tolerance bound at 95% confidence and 95% coverage, at or above 400 N, with k = 2.220 for n = 30.

  5. 0508:44

    Round 1 sent the result table when the question asked for the method

    Regulatory affairs manager

    Three columns, read left to right: what 1.12 asked, what the team sent back then, and how 2.07 words it now. That first answer gave Table 6 and the means, nothing else. The line under them names the miss in plain terms: the sample size rationale and the analysis method were never in the technical file.

  6. 0608:45

    Both lower bounds recomputed from Table 6, and both clear 400 N

    Regulatory affairs manager

    The draft shows its sums: 468.2 − 2.220 × 14.6 gives 435.8 N for the 45 mm reload, and 497.5 − 2.220 × 17.9 gives 457.8 N for the 60 mm. It also says why 30: a spread as wide as 31.5 N still clears the limit, against 16 N seen in engineering builds. Eleven citations sit in the text.

  7. 0708:46

    She rewrites the opening line and signs as maker

    Regulatory affairs manager

    She replaces the draft's opening line with her own, saying first what Round 1 left out, and signs with her own password. Her sentence is marked as not compared, so whoever checks it has to read her words, since no agent stands behind them.

  8. 0808:48

    His check stays locked until the answer has been on screen long enough

    Design quality engineer

    He linked the protocol but did not make this answer, so the check is his to give. It stays locked until he has scrolled to the end and the answer has stayed open for its length. He reads the sums against the protocol he knows, then signs as checker.

  9. 0908:50

    16 of 16 required items opened, and Round 2 is signed at 08:50

    Person responsible for regulatory compliance

    His list holds every major, the two minor repeats, the minor gap, the post-market item and a drawn sample of three minors. He had opened 15 by the end of last week; 2.07 was the last. His signature carries its meaning: this response keeps the technical documentation accurate and up to date.

Thirty units per reload size, and the tolerance bound sum behind 2.07

The evidence finder takes the means and spreads from Table 6 of the verification report and the factor from protocol section 5.2.

CheckValue
Acceptance, one-sided lower bound at 95% confidence and 95% coverageat or above 400 N
Tolerance factor for n = 30k = 2.220
45 mm reload: 468.2 − 2.220 × 14.6435.8 N
60 mm reload: 497.5 − 2.220 × 17.9457.8 N
Spread the plan could absorb: (470 − 400) ÷ 2.22031.5 N
Spread seen in engineering builds16 N
Fallback success-run plan, no failures allowed59 units

demoSample data, from the working solution. Thirty was set before testing so that the bound clears 400 N for any spread as wide as 31.5 N, about twice what the builds showed.

Around the round

Gaps, letters and signatures behind each notified body deficiency

What the engineer, the clinical evaluator, the signatory and regulatory operations open on the same review.

Tested on an earlier buildItem 2.11: the electromagnetic compatibility report tested firmware 2.2 on board rev B. The released build is 2.4 on rev C, so it is a gap with an owner.
Three gaps, promised for Round 3Each gap says what the file shows today and what will be delivered, with its owner and due date. The post-market item sits beside them.
The post-market itemItem 2.23 went to the post-market team as one line. Their signed document is attached by reference, and no agent opened it.
The letter, as receivedSix pages split into 23 items kept word for word, each marked with its number and page. Round 1's 31 items sit on the next tab.
The response, in letter orderThe 23 rows as the reviewer will read them, with each answer's status and citations. Only signed answers enter; the pack downloads after signature.
Signatures on the recordMaker and checker signatures for each answer, with the reason, what the signer attested and the session. The rows export as CSV.

demoSample data, from the working solution.

Repeats, older builds and revisions that changed after the answer was made

Things a tired team passes in the last week of a round.

A repeat that looks new

2.07 is worded differently from 1.12. Matched to it, the miss is plain: a result table went where a method was asked.

Evidence from the wrong firmware

The electromagnetic compatibility report tested 2.2 on board rev B. Released is 2.4 on rev C, so 2.11 becomes a gap, never a claim.

A risk report superseded mid-round

When rev 9 of the risk management report replaced rev 8, the three answers citing rev 8 lost their signatures and were made again.

A label that is approved but not yet in force

Answers citing the new instructions for use say when that revision takes effect, so the reviewer reads the right one.

demoSample data, from the working solution.

Five people sign a round, and the maker never checks their own answer

They start from different items.

Regulatory affairs manager
Sees
The rounds, the repeats and the next open item
Signs
Makes each repeat and the labeling answers; checks the others
Design quality engineer
Sees
Tested against released revisions, and the sums
Signs
Makes technical answers, checks repeats, owns the gaps
Clinical evaluation specialist
Sees
Clinical items and the sections they cite
Signs
Makes clinical answers and sends back drift with a reason
Person responsible for regulatory compliance
Sees
Majors, repeats, gaps, the post-market item and a drawn sample
Signs
Signs the round after opening each required item
Regulatory operations publisher
Sees
The signed pack, read only
Signs
Uploads only what was signed
Inside the round

Seven agents split, match and draft, and not one of them signs an answer

They split, match, find and draft. People make, check and sign.

Letter splitter

Splits the letter into numbered items, word for word, with their pages.

  • Never rewords the notified body's text
File mapper

Reads each item's grade and maps it to its file part and the documents that answer it.

  • Never guesses a part the letter does not support
Round matcher

Finds the earlier item a new one repeats and names what the last answer missed.

  • Never calls a repeat without showing both wordings
Evidence finder

Opens the technical file, risk file and lifecycle records, and compares tested with released revisions.

  • Never cites a page it did not open
  • Never opens the post-market team's document
Answer drafter

Drafts with a citation on each value and shows each sum it redoes.

  • Never answers a gap with words
  • Never signs or sends
Post-market router

Sends post-market items to that team as one line and attaches their signed answer by reference.

  • Never reads, summarizes or trends it
Response assembler

Builds the response pack once the round is signed.

  • Never includes an item that is not final

What regulatory affairs teams ask about notified body deficiency rounds

What is notified body deficiency response?

Notified body deficiency response means answering the numbered questions a notified body sends after reading a technical file. Here agents split the letter, match each repeat to its first question, and draft from the file with citations, while named people make, check and sign.

How does it know a question is a repeat when the wording changed?

The round matcher sets the new item beside the earlier question and the answer the team sent, and shows both wordings before it calls a match. A person can see the reason and disagree.

What happens when the file cannot answer an item?

It is marked a gap, with an owner, a due date and what will be delivered. The drafter does not fill it with words, and the gap waits for the next round as a commitment.

Will an agent open post-market data?

No. Post-market items go to the post-market team as one line, and their signed document is attached by reference. No agent opens it, summarizes it or counts anything in it.

Can someone check an answer without reading it?

The check stays locked until the answer has been on screen for a time set by its length and scrolled to its end. Words a person typed are marked so the checker reads them, and nobody may check their own answer.

What if something changes after the round is signed?

Sending any item back clears the round signature, marks the pack unsigned and stops the download. The signatory signs again on what is final.

Where does the signed response go?

Regulatory operations download the signed pack, with the answers, the evidence list and the signatures, and upload it to the notified body's portal themselves.

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Try it on your last deficiency letter
and the round before it.

We will match each repeat to its first question and show what the last answer left out.

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